FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FEMORAL
MDR report key: 1242667
·
Received November 20, 2008
Report
- Report Number
- 1818910-2008-05180
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 27, 2008
- Report Date
- October 27, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT REPORTED PAIN. BASED ON THE INVESTIGATION FINDINGS, THE NEED TO CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY FEMORAL | TOTAL KNEE REPLACEMENT | HSA | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |